Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337324
Status:
COMPLETED
Last Update Posted:
2006-06-15
First Post:
2006-06-14
Brief Title:
Electromagnetic Stimulation FREMS in Patients With Painful Diabetic Neuropathy
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Clinical Assessment of Transcutaneous Neurostimulation and Biofeedback FREMSin Patients With Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2002-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We postulate that frequency-modulated electromagnetic stimulation FREMS may decrease pain in patients with painful diabetic neuropathy
Detailed Description:
The stuy was designed as a randomized double-blind placebo-controlled cross-over trial Each patient received two series of ten treatments of either FREMS or placebo in random sequence with each series lasting no more than three weeks Primary outcomes daytime and night-time pain scores an secondary outcomes Motor and sensory nerve conduction velocity sensory tactile perception foot vibration perception threshold quality of life cutaneous microvascular flow partial tissue tension of oxygen and carbon dioxide were measured at baseline after FREMSplacebo series and after 4 months follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None